Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

NCT03646474 | Completed

• 1 other identifier: 201617027.2p
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The Tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.

Conditions

Cytoreductive Surgery

Outcome Measures

Primary Outcomes (1)

• change in blood loss

  Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).

  1st 24 hours.

Study Arms (2)

tranexamic acid group

ACTIVE COMPARATOR

Drug: tranexamic Acid infusion

placebo group

PLACEBO COMPARATOR

Drug: saline infusion

Interventions

tranexamic Acid infusion DRUG

The tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision.

tranexamic acid group

saline infusion DRUG

In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery.
• Age above 18 years \& less than 65 years.

You may not qualify if:

• Thrombophilia or any bleeding disorder.
• Previous or active thromboembolic disease.
• Family history of thromboembolism.
• Known Allergy to TA.
• Liver dysfunction.
• Preexisting renal dysfunction (serum creatinine \>1.2 mg/dL).
• Coronary stent insertion within a year prior to operation.
• Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure),
• Lifelong warfarin therapy for thromboembolism prophylaxis.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor of Anesthesia ICU and pain Relief

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: August 30, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

EG (1)